Plantar fasciitis (PF), a leading cause of persistent heel pain, results in almost a million physician visits annually. Conservative treatment is often the first line of management with insoles being frequently prescribed. While multiple studies have compared insoles based on the degree of customization to foot contour, the literature is lacking in data comparing insoles based on their material. In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and carbon fiber insoles in the treatment of PF, using a set of patient-reported outcomes.
Carbon fiber insoles (VKTRY, Milford, CT, USA) were initially designed to increase ground forces leading to a harder push off for faster running or higher jumping. To enable energy return, the insoles require extreme rigidity and therefore are composed of a full-length carbon-fiber base. The highly rigid construct of the carbon fiber can potentially benefit patients with plantar fasciitis by using these insoles in their own shoes, which could lead to more effective pain management, increased compliance, and improved patient outcomes. While this insole is currently being widely used by athletes, the application of this insole for PF patients has not been explored. Therefore, the aim of this study is to understand how patients respond to the these insoles compared to current standard orthotics (Superfeet Green, Superfeet Worldwide LLC. WA, USA and Aetrex L20, Aetrex Inc, NJ, USA) in a blinded randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Arch support orthotic
Massachusetts General Hospital
Boston, Massachusetts, United States
PROMIS-Pain interference
measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities
Time frame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
PROMIS-Pain intensity
assesses how much a person hurts. Patients are usually able to provide quantitative pain intensity estimates relatively quickly
Time frame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
Foot and Ankle Outcome Score
a 42-item questionnaire with 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (ADL) (17 items), sports/recreation (5 items), and quality of life (4 items
Time frame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
Visual Analogue Scale for pain
A Visual Analogue Scale (VAS) is one of the pain rating scales
Time frame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
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